University Ethics Committee APPLICATION FORM FOR ETHICAL APPROVAL (UEC1) N.B. The UEC Guidelines for Ethical Research with Human Subjects must be read prior to the completion of this form. Notes for each section of the application are provided under Section 2 (pp 11-12) of the Guidelines. 1 Name of principal investigator School/Address Position 2 Name of supervisor/director of studies (for undergraduate/ postgraduate applications only) School/Address Position 3 Title of Study 4 What is the primary purpose of this study? Original research  Audit  Undergraduate dissertation  Postgraduate dissertation  Other (please detail)  5 Has the proposed study been submitted to any others ethics committee? Has approval been given? 6 What is the justification for the research? What is the background? Why is this an area of importance? 7 Give a full summary of the purpose, design and methodology of the planned research, including a brief explanation of the theoretical framework that informs it. 8 How has the scientific quality of the research been assessed? Independent external review  Review within a company  Review within a multi-centre research group  Review within the Chief Investigator’s institution or host organisation  Review within the research team  Review by educational supervisor  Other (please detail)  9 Is the power of the study sufficient to answer the question that is being asked? Please indicate the power calculations used for the required sample size, including any assumptions you may have made. If you consider that power calculations are not appropriate, please explain why. 10 What statistical tests will you apply? 11 Does the research involve any physically invasive procedures? Are there any known hazards associated with these procedures? 12 Will individual or group interviews/questionnaires discuss any topics or issues that might be sensitive, embarrassing or upsetting, or is it possible that criminal or other disclosures requiring action could take place during the study (eg during interviews/group discussions or use of screening for drugs) 13 (a) Does the research involve any deception regarding aims and objectives? (b) Will the research participants be debriefed? When? How? By whom? 14 What is the expected duration of participation in the study for each participant? 15 How will potential participants in the study be (i) identified, (ii) approached and (iii) recruited? 16 What measures have been put in place to ensure confidentiality of personal data? Give details of whether any encryption or other anonymisation procedures will be used and at what stage. 17 Who will have access to the data and what steps will be taken to ensure data remains confidential? 18 What is the potential for benefit to research participants? 19 Will informed consent be obtained from the research participants? Yes  No  If yes, give details of who will obtain consent and how it will be done. Give details of any particular steps to provide information (in addition to a written information sheet) eg videos, interactive materials. Please note that a copy of the subject information sheet must be included with this application. If consent is not to be obtained, please explain why not. 20 Will a signed record of consent be obtained? 21 How long will the participant have to decide whether or not to take part in the research? 22 Will subjects be informed that they can withdraw at any time from the study? 23 Will the participants be from any of the following groups? Children under 16  Adults with learning disabilities  Adults who are unconscious or severely ill  Adults with a terminal illness  Adults in emergency situations  Adults with mental illness (particularly if detained under Mental Health Legislation)  Adults with dementia  Adults in Scotland who are unable to consent for themselves  Those who could be considered to have a particularly dependent relationship with the investigator, eg those in care homes, medical students  Other (please detail)  Please justify their inclusion. 24 Are there any special pressures that might make it difficult for people to refuse to take part in the study (eg the potential participants are students of the investigator)? 25 Will the study result in financial payment or payment in-kind to the applicants/to the department? Please specify amounts etc involved. 26 Where will this research take place? 27 How are the costs of this study to be met? 28 Please describe any other ethical considerations which need to be taken into account by the Ethics Committee? Please indicate which documents are enclosed with this application: Subject/patient/participant information sheet/leaflet  Consent form  Copy of protocol  Letters to participant  Letter to parents/guardians/gatekeepers etc  Letter of ethical committee approval or other approvals  Other relevant materials (please indicate)  The information supplied above is, to the best of my knowledge and belief, accurate. I have read the notes to investigators and clearly understand my obligations and the rights of subjects/study participants, particularly in relation to obtaining valid consent. Signature of Principal Investigator: Date: Signature of Supervisor/ Director of Studies (if applicable): Date: